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The purpose of this study is to compare the effects of a femoral nerve block vs. an adductor canal block on pain and quadriceps muscle strength for knee arthroscopy surgery.
Patients undergoing arthroscopic knee surgery (ACL and non-ACL surgery) typically receive an ultrasound-guided femoral nerve block or an adductor canal block in the pre-operative phase for post-operative pain control. While an effective method for post-operative analgesia, the femoral nerve block is associated with profound quadriceps weakness for the duration of the nerve block, which can impair ambulation, rehabilitation, and increase the risk of falls. The more distal adductor canal block, however, contains primarily sensory branches of the femoral nerve and has been been purported by small volunteer studies to provide equally effective analgesia with minimal motor block and quadriceps weakness (as compared to femoral nerve block).
The investigators will prospectively randomize patients undergoing knee arthroscopy at the UCSF Orthopaedic Institute to receive either a single-shot femoral nerve or adductor canal block pre-operatively after taking baseline measurements of quadriceps strength (quantified by maximum voluntary isometric contraction). The quadriceps muscle strength will be checked 20 minutes after the nerve block to assess strength. All patients will subsequently undergo a general anesthetic. The primary outcome variable will be post-block quadriceps strength as a percentage of baseline from pre-block values. Secondary outcome variables that will also investigated include: VAS pain score in the post anesthesia recovery unit and post-operative day 1, duration of nerve blockade, and perioperative opioid consumption.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Femoral Block | Active Comparator | Patients scheduled for knee arthroscopy will have a femoral nerve block done using 0.5% ropivacaine 20ml before surgery. |
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| Adductor Canal Block | Experimental | Patients scheduled for knee arthroscopy will have an adductor canal block done using 0.75% ropivacaine 13.3ml before surgery. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Femoral Nerve Block | Procedure | Patients having ACL reconstruction, meniscus surgery and knee arthroscopy |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Quadriceps Strength Related to the Nerve Block | Quadriceps strength will be tested with a dynamometer before the nerve block and 20 minutes after the nerve block prior to surgery. The dynamometer measures the strength of the quadriceps muscles in the seated position while pushing against the device. We are trying to measure the effect of both femoral and adductor canal nerve blocks on quadriceps strength. | Baseline and 20 minutes after the block prior to surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Numerical Pain Score From 0-10 | As this is an outpatient surgery, we will collect Numerical Pain Scores from the recovery room medical record after surgery as well as from the patients for the first 24 hours after surgery by contacting them at home the following day. We will evaluate the difference in patient pain scores between the two nerve blocks under study. The highest pain score for the 24-hour post-op period was collected for each participant. The median is reported for all participants. A pain score of 10 represents the worst pain. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pedram Aleshi, MD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSF Orthopedic Trauma Service | San Francisco | California | 94158 | United States |
IPD will be shared only if required for the publication of data.
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| ID | Title | Description |
|---|---|---|
| FG000 | Femoral Block for Knee Arthroscopy/Meniscus Surgery | Patients scheduled for knee arthroscopy will have a femoral nerve block done using 0.5% ropivacaine 20ml before surgery. |
| FG001 | Adductor Canal Block for Knee Arthroscopy/Meniscus Surgery |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 20, 2023 |
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| Adductor Canal Nerve Block | Procedure | Patients having ACL reconstruction, meniscus surgery and knee arthroscopy |
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| preoperative Femoral Nerve Block using 20ml of 0.5% ropivacaine | Drug |
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| Preoperative Adductor canal block with 0.75%% ropivacaine 13.3ml. | Drug |
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| worse pain in first 24 hours |
| Duration of Nerve Block | Patients will be contacted after surgery to determine when the nerve block wore off based on their increase in pain | 8 to 24 hours |
| Opioid Consumption Reported at mg of Morphine Equivalence | Data on the amount of pain medication consumed for the 1st 24 hours after surgery will be collected based on medications that were administered during surgery, in the recovery room and medications that patients took at home after discharge from the recovery room. All pain medications will be converted to morphine equivalence in milligrams and reported that way. The comparison will be the difference in mg morphine equivalence consumption between the two nerve block groups. | 2 days |
Patients scheduled for knee arthroscopy will have an adductor canal block done using 0.75% ropivacaine 13.3ml before surgery. |
| FG002 | Femoral Block for ACL Reconstruction | Patients scheduled for ACL reconstruction will have a sciatic nerve block and a femoral nerve block done using 0.5% ropivacaine 20ml before surgery. |
| FG003 | Adductor Canal Block for ACL Reconstruction | Patients scheduled for ACL reconstruction will have a sciatic nerve block and an adductor canal block done using 0.75% ropivacaine 13.3ml before surgery. |
| COMPLETED |
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| NOT COMPLETED |
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The data collection forms were missing for 10 participants. The data are not available to report, these data do not exist.
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| ID | Title | Description |
|---|---|---|
| BG000 | Femoral Block for Knee Arthroscopy/Meniscus Surgery | Patients scheduled for knee arthroscopy will have a femoral nerve block done using 0.5% ropivacaine 20ml before surgery. |
| BG001 | Adductor Canal Block for Knee Arthroscopy/Meniscus Surgery | Patients scheduled for knee arthroscopy will have an adductor canal block done using 0.75% ropivacaine 13.3ml before surgery. |
| BG002 | Femoral Block for ACL Reconstruction | Patients scheduled for ACL reconstruction will have a sciatic nerve block and a femoral nerve block done using 0.5% ropivacaine 20ml before surgery. |
| BG003 | Adductor Canal Block for ACL Reconstruction | Patients scheduled for ACL reconstruction will have a sciatic nerve block and an adductor canal block done using 0.75% ropivacaine 13.3ml before surgery. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Inter-Quartile Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| BMI | Median | Inter-Quartile Range | kg/m^2 |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Quadriceps Strength Related to the Nerve Block | Quadriceps strength will be tested with a dynamometer before the nerve block and 20 minutes after the nerve block prior to surgery. The dynamometer measures the strength of the quadriceps muscles in the seated position while pushing against the device. We are trying to measure the effect of both femoral and adductor canal nerve blocks on quadriceps strength. | The participants with data available are reported here. | Posted | Median | Inter-Quartile Range | Newtons | Baseline and 20 minutes after the block prior to surgery |
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| Secondary | Numerical Pain Score From 0-10 | As this is an outpatient surgery, we will collect Numerical Pain Scores from the recovery room medical record after surgery as well as from the patients for the first 24 hours after surgery by contacting them at home the following day. We will evaluate the difference in patient pain scores between the two nerve blocks under study. The highest pain score for the 24-hour post-op period was collected for each participant. The median is reported for all participants. A pain score of 10 represents the worst pain. | The participants with data available are reported here. | Posted | Median | Inter-Quartile Range | score on a scale | worse pain in first 24 hours |
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| Secondary | Duration of Nerve Block | Patients will be contacted after surgery to determine when the nerve block wore off based on their increase in pain | The participants with data available are reported here. | Posted | Mean | 95% Confidence Interval | minutes | 8 to 24 hours |
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| Secondary | Opioid Consumption Reported at mg of Morphine Equivalence | Data on the amount of pain medication consumed for the 1st 24 hours after surgery will be collected based on medications that were administered during surgery, in the recovery room and medications that patients took at home after discharge from the recovery room. All pain medications will be converted to morphine equivalence in milligrams and reported that way. The comparison will be the difference in mg morphine equivalence consumption between the two nerve block groups. | The participants with data available are reported here. | Posted | Median | Inter-Quartile Range | Morphine milligram equivalents (MME) | 2 days |
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Day of surgery and 24 hours post-operatively
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Femoral Block for Knee Arthroscopy/Meniscus Surgery | Patients scheduled for knee arthroscopy will have a femoral nerve block done using 0.5% ropivacaine 20ml before surgery. | 0 | 31 | 0 | 31 | 0 | 31 |
| EG001 | Adductor Canal Block for Knee Arthroscopy/Meniscus Surgery | Patients scheduled for knee arthroscopy will have an adductor canal block done using 0.75% ropivacaine 13.3ml before surgery. | 0 | 35 | 0 | 35 | 0 | 35 |
| EG002 | Femoral Block for ACL Reconstruction | Patients scheduled for ACL reconstruction will have a sciatic nerve block and a femoral nerve block done using 0.5% ropivacaine 20ml before surgery. | 0 | 33 | 0 | 33 | 0 | 33 |
| EG003 | Adductor Canal Block for ACL Reconstruction | Patients scheduled for ACL reconstruction will have a sciatic nerve block and an adductor canal block done using 0.75% ropivacaine 13.3ml before surgery. | 0 | 33 | 0 | 33 | 0 | 33 |
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A longer length of study time due to periods of elapsed time without a clinical research investigator to continue and complete the study, extended length of study due to COVID-19 pandemic and inability to enroll patients for an extended period.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Pedram Aleshi | University of California San Francisco | (415) 271-1627 | pedram.aleshi@ucsf.edu |
| Mar 20, 2023 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D000070598 | Anterior Cruciate Ligament Injuries |
| ID | Term |
|---|---|
| D007718 | Knee Injuries |
| D007869 | Leg Injuries |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
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| Asian |
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| Black |
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| Hispanic/Latino |
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| Native American or Pacific Islander |
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| OG003 | Adductor Canal Block for ACL Reconstruction | Patients scheduled for ACL reconstruction will have a sciatic nerve block and an adductor canal block done using 0.75% ropivacaine 13.3ml before surgery. |
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| OG003 | Adductor Canal Block for ACL Reconstruction | Patients scheduled for ACL reconstruction will have a sciatic nerve block and an adductor canal block done using 0.75% ropivacaine 13.3ml before surgery. |
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